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Sabuwar magani a sararin sama don Migraines

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Kamfanin Biohaven Pharmaceutical Holding Company Ltd. da Pfizer Inc. a yau sun sanar da cewa Kwamitin Kula da Magunguna don Amfani da Dan Adam (CHMP) na Hukumar Kula da Magunguna ta Turai (EMA) ya karɓi ra'ayi mai kyau don rimegepant, mai karɓar peptide mai alaƙa da calcitonin (CGRP) antagonist. , bayar da shawarar kashi na 75 MG na rimegepant (samuwa a matsayin kwamfutar hannu ta baki) don izinin tallace-tallace don duka maganin ciwon kai tare da ko ba tare da aura a cikin manya ba da kuma maganin rigakafi na episodic migraine a cikin manya waɗanda ke da akalla hare-haren migraine hudu a kowane wata. .            

Hukumar Tarayyar Turai (EC) za ta sake duba kyakkyawan ra'ayi na CHMP. EC za ta yanke shawarar ko za a amince da rimegepant, wanda sunan kasuwanci na Tarayyar Turai (EU) zai zama VYDURA™, EC za ta yanke shi kuma zai kasance mai aiki a duk ƙasashe membobin EU 27 da kuma Iceland, Lichtenstein, da Norway. Idan an amince, rimegepant zai zama farkon antagonist mai karɓa na CGRP na baki a cikin EU, kuma kawai maganin ƙaura da aka amince da shi don duka m da rigakafin rigakafi.

"Wannan furci na amincewa da rimegepant yana kawo mu kusa da burin mu na taimaka wa marasa lafiya da ke fama da wannan cuta mai raɗaɗi don samun maganin da ya dace," in ji Nick Lagunowich, Shugaban Duniya, Pfizer Internal Medicine. "Pfizer yana alfahari da samun sawun ƙafa mai ƙarfi a Turai, wanda zai taimaka kawo wannan muhimmin yuwuwar sabon zaɓin magani ga miliyoyin manya a Turai waɗanda ke zaune tare da ƙaura."

Kyakkyawan ra'ayi na CHMP ya dogara ne akan nazarin sakamakon daga binciken na uku na Phase 3 da kuma dogon lokaci, binciken aminci na buɗaɗɗen lakabi a cikin matsanancin jiyya na migraine, da kuma nazarin lokaci na 3 tare da tsawo na shekaru 1 a cikin rigakafin ciwon kai. A cikin waɗannan karatun, rimegepant yana da aminci kuma an jure shi sosai tare da ƙimar abubuwan da ba su da kyau kamar na placebo.

"Shawarwar don rimegepant alama ce mai mahimmanci ga al'ummar ƙaura," in ji Vlad Coric, MD, Babban Jami'in Gudanarwa da Shugaban Hukumar Biohaven. "Tare tare da Pfizer, mun sadaukar da kai don taimaka wa marasa lafiya kuma muna fatan samar da rimegepant ga marasa lafiya a Turai nan ba da jimawa ba, kuma a ƙarshe waɗanda suke a duk duniya, waɗanda ke fama da wannan cuta mai raɗaɗi, waɗanda yawancinsu ba su da gamsassun zaɓuɓɓukan magani a yau."

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edita

Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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